(83 days)
The SIENET MagicWeb and MagicLink I are medical communication devices (gateway devices). The MagicWeb is a web server intended to provide lowend image and report distribution. Images and reports can be viewed by accessing the server using commercially available Web Browsers. Images distributed by the MagicWeb are for viewing purposes and are not intended for primary diagnosis.
The MagicLink I is a gateway connection between SIENET and RIS/HIS systems. Patient demographic information and examination data (text only) are transferred across the gateway. This device is an accessory to hospital information systems.
This premarket notification covers the SIENET gateway product line, specifically, SIENET MagicLink I (ISI-Gateway) and MagicWeb (web server).
The SIENET MagicWeb and MagicLink I are medical communication devices (gateway devices). The MagicWeb is a web server intended to provide low-end image and report distribution. Images and reports can be viewed by accessing the server using commercially available Web Browsers. Images distributed by the MagicWeb are for viewing purposes and are not intended for primary diagnosis.
The MagicLink I is a gateway connection between SIENET and RIS/HIS systems. Patient demographic information and examination data (text only) are transferred across the gateway. This device is an accessory to hospital information systems.
These products support industry standard information transmission and communication protocols.
The provided text does not contain information about acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
The document is a 510(k) summary for the SIEMENS SIENET Gateway product line (MagicWeb and MagicLink I). It describes the device, its intended use (medical communication devices for image and report distribution, and data transfer), and claims substantial equivalence to previously marketed devices. The FDA letter confirms the substantial equivalence determination.
Therefore, I cannot fulfill your request for the detailed study information.
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.